TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fraction

TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fraction - DoPING-HFpEF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48659

Enrollment

Registered

2018-11-16

Start date

2019-04-29

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure with preserved ejection fraction

Interventions

Trimetazidine tablet 20mg TID (BID if eGFR 30-60 ml/min/1.73m2) or placebo for 2 times 3 months with a 2-week washout period.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Diagnosis of HFpEF: a. signs/and or symptoms of heart failure, NYHA II or higher (and ambulant) b. LV ejection fraction * 50% (by any modality) c. evidence of LV diastolic dysfunction (PCWP at rest >15mmHg and/or PCWP during exercise * 25mmHg; diastolic dysfunction grade II or higher (echocardiography) with a NT-proBNP level >125 pg/mL) d. no other significant cardiac (e.g. significant valvular disease) or extra-cardiac condition (e.g. severe COPD) that explains symptoms 2. Clinically stable (no change in diuretic for >1 month), co-morbidities managed 3. Informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Current acute decompensated heart failure, requiring augmented therapy with intravenous diuretics, vasodilator and/or inotropic drugs; 2. Acute coronary syndrome, TIA/CVA, major surgery within the 3 months prior; 3. Suspected septal scar (e.g. due to myocardial infarction) which prohibits the measurement of PCr/ATP with MRS; 4. Unable to undergo the complete study protocol (RHC, MRI/MRS, 6MWD); 5. Contra-indication for trimetazidine (severe kidney failure with an eGFR

Design outcomes

Primary

Measure	Time frame
exercise PCWP measured by RHC	—

Secondary

Measure	Time frame
Key secondary endpoint: myocardial PCr/ATP-ratio measured by 31P-MRS Safety endpoint: (S)AE; Metabolic: trimetazidine plasma levels, mitochondrial function, insulin resistance (HOMA) Exploratory: NT-proBNP, 6MWD, quality-of-life (KCCQ, EQ-5D).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)