Clinical trial • Phase III • Cardiology

CINNARIZINE for Heart failure with preserved ejection fraction

Phase III trial of CINNARIZINE for Heart failure with preserved ejection fraction.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heart failure with preserved ejection fraction
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-09-2024
First CTIS Authorization Date
23-09-2024

Trial design

Randomised, active arms: spironolactone (oral) plus standard of care; eplerenone (oral) plus standard of care. control arm: standard of care alone. (specific trial dosing/schedule not detailed in the provided summary; product entries list max daily dose amount 50 mg.) Phase III trial in Sweden.

Randomised
Yes
Comparator
Active arms: Spironolactone (oral) plus standard of care; Eplerenone (oral) plus standard of care. Control arm: standard of care alone. (Specific trial dosing/schedule not detailed in the provided summary; product entries list max daily dose amount 50 mg.)
Target Sample Size
2000

Eligibility

Recruits 2000 No vulnerable populations selected. Written informed consent is required. No assent procedures or special consent handling for vulnerable groups are described in the available record..

Pregnancy Exclusion
Actual or potential for pregnancy
Vulnerable Population
No vulnerable populations selected. Written informed consent is required. No assent procedures or special consent handling for vulnerable groups are described in the available record.

Inclusion criteria

  • {"criterion_text":"- Written informed consent\n- Age ≥50 years\n- Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator. Patients may be enrolled as an outpatient or in-hospital at, or close to, the time of hospital discharge\n- Most recent left ventricular ejection fraction (LVEF) ≥40%\n- Elevated natriuretic peptide levels as defined by any of the following: a. most recent NT-proBNP >300 ng/L (or BNP >100 pg/mL) in sinus rhythm (at time of blood sampling); adjustments may be made for BMI according to table 3. b. most recent NT-proBNP >750 ng/L (or BNP >250 pg/mL) in atrial fibrillation (at time of blood sampling); adjustments may be made for BMI according to table 3. c. NT-proBNP >1200 ng/L (or BNP >400 pg/mL) within the last 12 months even if most recent value is lower\n- Regular use of loop diuretics, defined as daily or most days of the week\n- NYHA Class II-IV"}

Exclusion criteria

  • {"criterion_text":"- Previously enrolled in this study\n- Known EF <40% ever\n- Current absolute indication or contraindication for MRA in judgement of Investigator. In the absence of absolute indication, patients currently treated with an MRA may have the MRA discontinued and then included in the trial according to investigator judgement\n- Known chronic liver disease\n- Probable alternative explanations for symptoms such as: (a) Known primary cardiomyopathy that is hypertrophic with obstruction, constrictive, restrictive, infiltrative, or congenital (hypertrophic without current obstruction and other primary cardiomyopathies are allowed) (b) Primary valve disease (to exclude a patient, the valve disease must be primary AND the primary cause of the symptoms) (c) Significant chronic pulmonary disease requiring home O2 (d) Symptomatic anemia (hemoglobin is <10 g/dL (100 g/L) and this is the likely cause of the symptoms) (e) Right-sided HF not due to left sided HF\n- Heart transplant or LVAD recipient\n- Presence of cardiac resynchronization therapy (CRT) device\n- Systolic blood pressure <90 or >160 mm Hg at baseline (assessments documented in Medical Records within 30 days) *. *) Blood pressure taken by the patient themselves at home is accepted if no other data is documented within 30 days. The home measurement needs to be noted in Medical Records\n- K >5.0 mmol/L (non-hemolysis sample**; most recent, not older than 30 days). **) All K values in the trial refer to non-hemolysis samples. If hemolysis, blood test needs to be repeated.\n- Current dialysis\n- Current lithium use\n- Actual or potential for pregnancy\n- Participation in another interventional clinical trial where a mineralocorticoid receptor antagonist is studied. Co-enrollment in trials and observational studies of other medical and device interventions is permitted\n- Not suitable in the opinion of the Investigator due to severe or terminal comorbidity with poor prognosis, or characteristics that may interfere with adherence to trial protocol"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Time to CV death or first HF hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to CV death","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence rate for total HF hospitalizations","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to HF hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to all-cause mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence rate for total all-cause hospitalizations","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to all-cause hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence rate for all-cause hospitalization or all-cause mortality","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
Yes
Planned Sample Size
2000
Recruitment Window Months
121
Consent Approach
Written informed consent is required. Subject information and informed consent form documents are listed (e.g. L1_SIS and ICF). No mention of assent procedures or age-specific consent documents or languages is provided in the available record.

Geography

Total Number Of Sites
31
Total Number Of Participants
2000

Sweden

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
23-09-2024
Processing Time Days
27
Number Of Sites
31
Number Of Participants
2000

Sites

Site Name
Region Dalarna
Department Name
Hjärtkliniken
Contact Person Name
Fahed Sulaiman
Site Name
Region Vaestmanland
Department Name
Hjärtkliniken
Contact Person Name
Ingemar Lönnberg
Site Name
Soedersjukhuset AB
Department Name
Hjärtkliniken
Contact Person Name
Carin Corovic Cabrera
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Hjärtkliniken
Contact Person Name
Charlotta Ljungman
Contact Person Email
charlotta.ljungman@vgregion.se
Site Name
Region Vaermland
Department Name
Hjärtkliniken
Contact Person Name
Edit Floderer
Contact Person Email
region@regionvarmland.se
Site Name
Region Oestergoetland
Department Name
Hjärtkliniken Norrköping
Contact Person Name
Dimitrios Ftakas
Site Name
Region Gotland
Department Name
Vårdcentralen Hemse
Contact Person Name
Ann Hovland-Tånnerud
Site Name
Skaraborg Hospital-Vaestra Goetalandsregionen
Department Name
Hjärtkliniken
Contact Person Name
Magnus Peterson
Contact Person Email
magnus.peterson@vgregion.se
Site Name
Region Kalmar Laen
Department Name
Hjärtkliniken Oskarshamn
Contact Person Name
Sadegh Dolatabadi
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Forskningsenheten Kranskärl/svikt
Contact Person Name
Grunde Gjesdal
Contact Person Email
Grunde.Gjesdal@skane.se
Site Name
Region Vaesterbotten
Department Name
Hjärtkliniken Skellefteå
Contact Person Name
Jonas Andersson
Site Name
Region Skane Lasarettet I Landskrona
Department Name
Hjärtkliniken
Contact Person Name
Fredrik Kymle
Contact Person Email
Fredrik.kymle@skane.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Hjärtkliniken Östra sjukhuset
Contact Person Name
Michael Fu
Contact Person Email
michael.fu@vgregion.se
Site Name
Region Vaesternorrland
Department Name
Hjärtkliniken
Contact Person Name
Mohammad Kavianipour
Contact Person Email
mohammad.kavianipour@rvn.se
Site Name
Capio S:t Goerans Sjukhus AB
Department Name
Hjärtkliniken
Contact Person Name
Ulrika Löfström
Site Name
Kalthus Heart & Horse AB
Department Name
Hjärtmottagningen
Contact Person Name
Carl-Johan Lindholm
Site Name
Region Oerebro Laen
Department Name
Hjärtkliniken
Contact Person Name
Barna Szabo
Contact Person Email
barna.szabo@regionorebrolan.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Medicinkliniken Mölndals sjukhus
Contact Person Name
Per Parén
Contact Person Email
par.paren@vgregion.se
Site Name
Region Vaestmanland
Department Name
Hjärtkliniken
Contact Person Name
Emöke Fodor
Site Name
Region Soermland
Department Name
Vårdcentralen Mariefred
Contact Person Name
Tobias Reitberger
Site Name
Region Uppsala
Department Name
Kardiologen Akademiska sjukhuset
Contact Person Name
Tymon Wincenty Pol
Site Name
Region Soermland
Department Name
Vårdcenralen Centrum Flen
Contact Person Name
Kaj Possler
Contact Person Email
kaj.possler@regionsormland.se
Site Name
Region Stockholm
Department Name
Tema Hjärta Kärl Karolinska Universitetssjukhuset
Contact Person Name
Lars Lund
Contact Person Email
lars.lund@alumni.duke.edu
Site Name
Region Uppsala
Department Name
Internmedicin Akademiska sjukhuset
Contact Person Name
Micael Dimberg
Contact Person Email
michael.dimberg@akademiska.se
Site Name
Region Oestergoetland
Department Name
Hjärtkliniken
Contact Person Name
Henriette van der Wal
Contact Person Email
region@regionostergotland.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Kliniska Forskningsenheten
Contact Person Name
Patrik Svensson
Contact Person Email
Patrik.E.Svensson@skane.se
Site Name
Region Halland
Department Name
Hjärtkliniken
Contact Person Name
Petru Tutuianu
Site Name
Region Joenkoepings Laen
Department Name
Hjärtkliniken
Contact Person Name
Patric Karlström
Contact Person Email
kliniskastudierfuturum@rjl.se
Site Name
Region Blekinge
Department Name
Hjärtkliniken
Contact Person Name
Carl Thorsén
Contact Person Email
Carl.thorsen@regionblekinge.se
Site Name
Region Kalmar Laen
Department Name
Hjärtkliniken Västervik
Contact Person Name
Anna Stenström
Contact Person Email
anna.stenstrom@ltkalmar.se
Site Name
Danderyds Sjukhus AB
Department Name
Hjärtkliniken
Contact Person Name
Jonas Spaak
Contact Person Email
jonas.spaak@regionstockholm.se

Sponsor

Primary sponsor

Full Name
Region Uppsala
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
SPIRONOLACTONE
Active Substance
CINNARIZINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
marketingAuthNumber: -
Maximum Dose
50 mg
Investigational Product Name
EPLERENONE
Active Substance
ALTIZIDE, MICRONISED SPIRONOLACTONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
marketingAuthNumber: -
Maximum Dose
50 mg

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