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Acute Heart FailureDR-AHFNCT04331132

Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction

A study testing Tolvaptan 15 MG in people with Acute Heart Failure, run by Gia Dinh People Hospital at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Renal dysfunction, which comprises 10%-40% of acute heart failure patients (AHF), plays an important role in diuretic resistance mechanism. DR-AHF was designed to demonstrate the effectiveness of early tolvaptan (a vasopressin-2 receptor antagonist) add-on therapy in acute heart failure patients with renal dysfunction… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Acute Heart Failure
What is being tested?
Tolvaptan 15 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteVietnam
Study dates
1 Dec 2021to 26 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Admitted to hospital with a primary diagnosis of acute heart failure with wet-warm phenotype
  • Cumulative urine volume output < 300ml within 2 hours after the first dose of intravenous furosemide
  • eGFR at admission 15-60ml/min/1.73m2

Who cannot join

  • Acute coronary syndrome
  • Anuria
  • Sepsis
  • Consciousness impairment
  • Pregnant or breastfeeding women
  • Severe valvular heart diseases (severe valvular stenosis or regurgitation)
Show all 12Show fewer
  • Admission sodium level > 140 mEq/L
  • Serum total bilirubin > 3 mg/dL
  • Serum potassium > 5.5 mmol/L
  • Allergy or contraindication for tolvaptan
  • Emergency indication for hemodialysis
  • Cardiogenic shock or mechanical circulation support

Trial locations and contacts

1 site in 1 country.

Nhat M. Giang, M.D contact

+84919963999

minhnhat_210189@yahoo.com

Hai H. Nguyen, Ph.D contact

+84908247359

bsnguyenhoanghai@gmail.com

Vietnam1 site, 1 recruiting

  • Cardiology Department

    Ho Chi Minh City, 70000

    Hai H Nguyen, Ph.D, +84908247359, bsnguyenhoanghai@gmail.com

    Nhat M Giang, M.D, +84919963999, minhnhat_210189@yahoo.com

    Recruiting

Other trials in Vietnam

About this study

Renal dysfunction, which comprises 10%-40% of acute heart failure patients (AHF), plays an important role in diuretic resistance mechanism. DR-AHF was designed to demonstrate the effectiveness of early tolvaptan (a vasopressin-2 receptor antagonist) add-on therapy in acute heart failure patients with renal dysfunction and clinical evidence of loop diuretic resistance.

Read the detailed description

This is a single-center, open-label, randomized controlled trial, which will enroll 128 patients hospitalized due to AHF. These patients with wet-warm phenotype whose estimated glomerular filtration rates at admission are above 15 and below 60 mL/min/1.73 m2, and cumulative urine output <300 mL in 2 hours after the first dose of intravenous furosemide will be randomly assigned 1:1 to receive a standard care with uptitrating intravenous furosemide alone or a combination therapy with tolvaptan 15mg once daily for 2 days. The standard furosemide treatment will follow the modified 2019 Position Statement from the ESC Heart Failure Association. The primary endpoint is the cumulative urine output at 48 hour. Key secondary endpoints include the improvement of fractional excretion of sodium at 6 hour, the total dose of furosemide, the changes in the body weights, the net fluid loss, the lessening of diastolic dysfunction parameters on echocardiography, and the incidence of clinically relevant worsening renal function at 48 hour.

Being tested
Tolvaptan 15 MG
Keywords
acute heart failure, worsening renal function, loop diuretic resistance, vasopressin-2 receptor antagonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tolvaptan 15 MGDrug

    Also called Samsca

    vasopressin-2 receptor antagonist 15mg once daily is added-on to the conventional diuretic strategy

Study groups in NCT04331132
Study groupRoleWhat they receive
Conventional diuretic groupPlacebo comparatorThe conventional furosemide treatment will follow the modified 2019 Position Statement from the ESC Heart Failure Association
Receives: Drug: Tolvaptan 15 MG
Vasopressin-2 antagonist groupActive comparatorTolvaptan 15mg once daily for 2 days will be added-on the furosemide strategy based on the modified 2019 Position Statement from the ESC Heart Failure Association
Receives: Drug: Tolvaptan 15 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative urine volume output at 48h after randomization

    Urine volume in mL

    Measured: Hour 48

Secondary outcomes (12)

  1. Cumulative dose of furosemide at 48h after randomization

    Furosemide dose in mg

    Measured: Hour 48

  2. Symptom of dyspnea by 7-point Likert scale at 24h and 48h after randomization

    3: markedly better, 2: moderately better, 1: minimally better, 0: no change, -1: minimally worse, -2: moderately worse, -3: markedly worse

    Measured: Hour 24, Hour 48

  3. Changes in body weight at 24h and 48h after randomization

    weight in gram

    Measured: Hour 24, Hour 48

  4. Incidence of clinically relevant worsening renal function at 24h and 48h after randomization

    An increase in serum creatinine ≥ 0.3 mg/dL within 48 hours accompanying doubling the dose of furosemide according to the diuretic treatment protocol

    Measured: Hour 24, Hour 48

  5. Changes in serum electrolytes measured at 12h, 24h and 48h after randomization

    Changes in serum sodium (mmol/L), potassium (mmol/L), chloride (mmol/L)

    Measured: Hour 12, Hour 24, Hour 48

  6. Changes in urine electrolyte excretion at 6h, 24h and 48h

    Increase in sodium (mmol/L), potassium (mmol/L) and chloride (mmol/L) excretion adjusted for urine creatinine (umol/L)

    Measured: Hour 6, Hour 24, Hour 48

  7. Changes in NT-proBNP at 48h after randomization

    Changes in NT-proBNP (pg/mL)

    Measured: Hour 0, Hour 48

  8. Changes in mitral e' on echocardiography

    Average of septal e' (cm/s) and lateral e' (cm/s) on tissue doppler imaging in apical 4-chamber view

    Measured: Hour 24, Hour 48

  9. Changes in E/e' ratio on echocardiography

    The ratio between mitral E (cm/s) and average e' (cm/s)

    Measured: Hour 24, Hour 48

  10. Changes in left atrial volume on echocardiography

    Average of left atrial volumes (ml) by Simpson's rule in apical 4-chamber and 2-chamber view

    Measured: Hour 24, Hour 48

  11. Changes in tricuspid regurgitation maximal velocity on echocardiography

    Tricuspid regurgitation maximal velocity (m/s) by continuous wave doppler in apical 4-chamber view

    Measured: Hour 24, Hour 48

  12. Changes in inferior vena cava maximal diameter on echocardiography

    Inferior vena cava maximal diameter (mm) in subcostal view

    Measured: Hour 24, Hour 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start1 Dec 2021
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion26 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Acute heart failure patients with wet-warm phenotype whose estimated glomerular filtration rates at admission are above 15 and below 60 mL/min/1.73 m2, and cumulative urine output \<300 mL in 2 hours after the first dose of intravenous furosemide will be randomly assigned 1:1 to receive a standard care with uptitrating intravenous furosemide alone or a combination therapy with tolvaptan 15mg once daily for 2 days
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04331132
Sponsor's protocol ID
92/CN-HĐĐĐ
Acronym
DR-AHF
Status last verified
Sep 2021
First submitted
27 Mar 2020
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

    PubMed 27206819

  • Felker GM, Ellison DH, Mullens W, Cox ZL, Testani JM. Diuretic Therapy for Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 17;75(10):1178-1195. doi: 10.1016/j.jacc.2019.12.059.

    PubMed 32164892

  • Mullens W, Damman K, Harjola VP, Mebazaa A, Brunner-La Rocca HP, Martens P, Testani JM, Tang WHW, Orso F, Rossignol P, Metra M, Filippatos G, Seferovic PM, Ruschitzka F, Coats AJ. The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019 Feb;21(2):137-155. doi: 10.1002/ejhf.1369. Epub 2019 Jan 1.

    PubMed 30600580

  • Minh NG, Hoang HN, Maeda D, Matsue Y. Tolvaptan Add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction (DR-AHF): Design and Rationale. Front Cardiovasc Med. 2022 Jan 27;8:783181. doi: 10.3389/fcvm.2021.783181. eCollection 2021.

    PubMed 35155599

Questions about this trial

What is this clinical trial studying?

A study testing Tolvaptan 15 MG in people with Acute Heart Failure, run by Gia Dinh People Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nhat M. Giang, M.D (+84919963999, minhnhat_210189@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative urine volume output at 48h after randomization (time frame: Hour 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04331132, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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