Trials Sponsors Conditions Drugs Pricing

Conditions

Heart Failure with Mid-range Ejection Fraction Heart Failure with Preserved Ejection Fraction

Keywords

heart failuremid-range ejection fractionpreserved ejection fractiondiastolic dysfunctionSpironolactoneMineralcorticoid Receptor Antagonist

Outcome Measures

Primary Outcomes (1)

Primary Objective: Cumulative number of primary composite events of cardiovascular (CV) death and total HF hospitalizations
Cumulative number of primary composite events of cardiovascular (CV) death and total (first and recurrent) HF hospitalizations in symptomatic HF patients (NYHA II-IV) with mid-range (LVEF 40- 49 %) or preserved (LVEF ≥ 50 %) ejection fraction.
Time Frame: Total follow up time (up to 48 months)

Secondary Outcomes (1)

Secondary Objective: Comparison of spironolactone to placebo in reducing the rate of hospitalisations and deaths
Time Frame: Total follow up time (up to 48 months)

Study Arms (2)

Arm A

EXPERIMENTAL

Experimental: Spironolactone Spironolactone (an aldosterone antagonist) in tablet form taken daily. The initial study drug dose is 25 mg/day (one tablet) and may be titrated up to 50 mg/day (two tablets) within 4 weeks if kidney function at VR was \> 30 mL/min/m2 and potassium \< 4.5 mmol/L.

Drug: Experimental: Spironolactone

Arm B

PLACEBO COMPARATOR

Placebo Comparator: Placebo Placebo of Spironolactone in tablet form taken daily with dosage escalation rules in accordance with dosage of the study drug Spironolactone.

Drug: Placebo Comparator

Interventions

Experimental: SpironolactoneDrug

Spironolactone (an aldosterone antagonist) in tablet form taken daily. The initial study drug dose is 25 mg/day (one tablet) and may be titrated up to 50 mg/day (two tablets) within 4 weeks if kidney function at VR was \> 30 mL/min/m2 and potassium \< 4.5 mmol/L.

Arm A

Placebo ComparatorDrug

Placebo of Spironolactone in tablet form taken daily with dosage escalation rules in accordance with dosage of the study drug Spironolactone.

Eligibility Criteria

Age50 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent.
Male or female, age ≥ 50 years

Sponsors & Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Othercollaborator
Echo Core Lab Berlin
Type not reportedcollaborator

Study Sites (69)

Medical University of Graz

Graz, 8010, Austria

Medical University Innsbruck

Innsbruck, 6020, Austria

Clinic Klagenfurt Wörthersee

Klagenfurt, 9020, Austria

University Hospital St. Pölten

Pölten, 3100, Austria

Medical University of Vienna

Vienna, 1090, Austria

Besançon University Hospital

Besançon, 25030, France

Centre Hospitalier de Beziers

Béziers, 34500, France

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

Burkert Pieske, Prof. MD
Charité University of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

743 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Univ. Prof. Dr. med. Frank Edelmann

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 27, 2021

Study Start

November 1, 2018

Actual (reported)

You may not qualify if:

Hyperkalemia (potassium level ≥ 5.5 mmol/L) within the past two weeks before VR
Hyponatraemia (sodium level \< 135 mmol/L) prior to randomization
Severe renal dysfunction, defined as an estimated glomerular filtration rate of less than 30 mL/min/1.73m2) as calculated by the Modification in Diet in Renal Disease (MDRD) formula at Visit 1 or serum creatinine level ≥ 1,8 mg/dl (\> 160 μmol/ml)
History of anuria or acute renal failure (as defined by the RIFLE criteria for AKI; see Appendix XVIII.3) within the past two weeks before VRenal dysfunction, defined as an estimated glomerular filtration rate of less than 30 mL/min/1.73m2) as calculated by the Modification in Diet in Renal Disease (MDRD) formula at VScr/VR or serum creatinine level ≥ 1,8 mg/dl (\> 160 μmol/ml)History of anuria or acute renal failure (as defined by the RIFLE criteria for AKI; see Appendix XVIII.3) within the past two weeks prior to randomization
Acute coronary syndrome (including MI) and elective PCI within 30 days prior to VR.
Cardiac surgery, other major CV surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to VR
Current acute decompensated HF requiring augmented therapy with i.v. diuretics, i.v. vasodilators and/or i.v. inotropic drugs. Patients are eligible after initial stabilization.
Probable alternative diagnoses that in the opinion of the investigator could account for the patient's HF symptoms (i.e., dyspnea, fatigue) such as significant pulmonary disease (including primary pulmonary HTN), anemia or obesity. Specifically, patients with the following are not eligible for randomization:
Severe pulmonary disease including chronic obstructive pulmonary disease (COPD) or severe asthma bronchiale ( (ie requiring home oxygen, chronic nebulizer therapy, chronic oral steroid therapy) or
anemia (hemoglobin \< 10 g/dL males and \< 9.5 g/dL females), or
body mass index (BMI) \> 40 kg/m2
Evidence of right sided HF in the absence of left-sided structural heart disease.
Specific etiologies such as infiltrative, genetic hypertrophic cardiomyopathy, pericardial constriction, sarcoidosis, amyloidosis and any other storage diseases.
Clinically significant congenital heart disease underlying heart failure.
Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and uncontrolled persistent or permanent atrial fibrillation (AF) or flutter (with a heart rate \> 100 beats per minute (bpm), RACE II) during VR. If AF with HR \> 100/min, the patient may be rescreened after treatment for rate control.
+18 more criteria

Study Stopped

Spironolactone in the Treatment of Heart Failure

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Arm A

Arm B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (69)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Arm A

Arm B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (69)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations