Dapagliflozin in patients with Right Heart Failure (Dapa-RHF)

Phase 1

• Conditions: Right heart failure defined as (criteria a-c must all be fulfilled):a) Reduced right ventricular systolic function or RV strain defined as at least one of the followingb) N-terminal pro-BNP (NT-proBNP) >125 pg/mlc) Clinical signs of right cardiac congestion or need for diuretic therapy to prevent signs of congestion; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-000420-38-DE
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. The Patient is willing and able to participate and provide written informed consent;
2. Age = 18 years and < 90 years;
3. Presence of RHF defined as (criteria a-c must all be fulfilled):
a) Reduced right ventricular systolic function or RV strain defined as at least one of the following
- tricuspid annular plane systolic excursion (TAPSE) <16 mm
- RV fractional area change (FAC) <35%
- Systolic pulmonary artery pressure (PAP sys) =35 mmHg combined with an extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography

b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml

c) Clinical signs of right cardiac congestion (edema, and / or extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography and / or pleural effusion on sonography and / or chest radiograph) or need for diuretic therapy to prevent signs of congestion

4. For women of childbearing potential (until 1 year after menopause):
a) Negative pregnancy test AND
b) Use of highly effective methods of contraception during treatment plus 5 days after the end of study drug administration

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%)
2.Pulmonary arterial hypertension (PAH, PH Group I)
3.Acute (within 30 days) pulmonary embolism
4.Acute (within 30 days) right ventricular myocardial infarction
5.Current medication with any SGLT2 inhibitor
6.Chronic kidney disease (CKD) or acute kidney injury with eGFR < 25 ml/min/1,73 m², or end-stage renal failure with the need for chronic dialysis treatment
7.Systolic blood pressure (SBP) <90 mmHg at randomization on 2 consecutive measurements
8.Any contraindication for cardiac magnetic resonance imaging (MRI)
9.Known intolerance or hypersensitivity to dapagliflozin
10.Known contraindication for the treatment with dapagfliflozin
11.Type 1 diabetes mellitus
12.Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent
13.Current participation in another interventional trial
14.Pregnancy or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that dapagliflozin on top of standard of care is superior in reducing the primary outcome in patients with chronic RHF compared to standard of care plus placebo.;Secondary Objective: To investigate the influence of dapagliflozin in patients with chronic right heart failure on secondary outcomes as changes in quality of life, right ventricular ejection fraction, exercise capacity, NYHA class, cardiac imaging parameters, renal function or laboratory parameters;Primary end point(s): Change in serum NT-proBNP level from baseline to end of treatment (Delta-NT-proBNP);Timepoint(s) of evaluation of this end point: End of treatment<br>(week 12 and week 24)