NCT04475042

Brief Summary

A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

July 8, 2020

Last Update Submit

September 18, 2020

Conditions

Heart Failure, Diastolic

Outcome Measures

Primary Outcomes (2)

  • Left Ventricular (LV) e'

    echocardiographically measured

    13 weeks

  • E/e'/LV end-diastolic volume index

    echocardiographically measured

    13 weeks

Secondary Outcomes (5)

  • Kansas City Cardiomyopathy Questionnaire

    13 weeks

  • 6-minute walk test

    13 weeks

  • Left atrial volume

    13 weeks

  • Diastolic parameters

    13 weeks

  • Left atrial function

    13 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Dapagliflozin - washout period - placebo

Drug: DapagliflozinDrug: Placebo

Group B

ACTIVE COMPARATOR

Placebo - washout period - Dapagliflozin

Drug: DapagliflozinDrug: Placebo

Interventions

DapagliflozinDRUG

10mg od

Group AGroup B
PlaceboDRUG

Placebo

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years at time of screening
  • Symptomatic chronic heart failure patients with diagnosis of heart failure and:
  • NYHA class II-IV
  • Preserved systolic Left Ventricular (LV) function, defined by: LV Ejection Fraction (LVEF) ≥ 50% and LV end-diastolic volume index \<97 ml/m2
  • Evidence of diastolic LV dysfunction and at least 1 out of the 5 following additional criteria:
  • H2FPEF score ≥ 6;
  • HFA-PEFF score ≥ 5;
  • Pulmonary capillary wedge pressure \> 15 mmHg at rest or \> 25 mmHg with exercise assessed with right heart catheterization;
  • Cardiac MRI T1 derived extracellular volume \<29% at screening
  • Oral diuretics, if prescribed to the patient according to local guidelines and at the discretion of the investigator, should be stable for at least 1 week prior to baseline visit
  • Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial

You may not qualify if:

  • Reduced systolic LV function (LVEF \< 50%), measured at any time point in the history of the patient
  • Obstructive coronary artery disease with evidence of ischemia
  • Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to screening visit
  • More than mild valve stenosis
  • More than moderate aortic and/or mitral valve regurgitation
  • Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. hemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (stress cardiomyopathy), hypertrophic (obstructive) cardiomyopathy or known pericardial constriction
  • History of mitral valve repair or replacement
  • Atrial fibrillation or atrial flutter with a resting heart rate \> 110 bpm at screening
  • Acute decompensation that requires intravenous loop diuretics
  • Systolic blood pressure ≥ 180 mmHg. If SBP \> 150 mmHg and \< 180 mmHg, the patient should be receiving at least 3 antihypertensive drugs at screening or baseline visit
  • Symptomatic hypotension and/or a SBP \< 100 mmHg at screening or baseline visit
  • Impaired renal function, defined as eGFR \< 30 ml/min/1.73 m2
  • Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3x upper limit of normal or history of cirrhosis with evidence of portal hypertension
  • Hemoglobin \< 9 g/dl at screening
  • Chronic obstructive pulmonary disease, more than GOLD class 2
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLVG

Amsterdam, North Holland, 1091, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Central Study Contacts

Marielle Scheffer, MD

CONTACT

0031205994889mailcardio.research@olvg.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 17, 2020

Study Start

July 1, 2020

Primary Completion

November 1, 2021

Study Completion

May 1, 2022

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

NL(1)