Heart FailurePhase 4NCT01752543
Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure Patients
A Phase 4 study testing Conivaptan in people with Heart Failure, run by Finn Gustafsson at 1 site in Denmark.
Trial summary
The purpose of the present study is to evaluate the effects of a blockade of the vasopressin system and central hemodynamic system in heart failure (HF) patients during physical exercise. The significance of the vasopressin system during physical exercise is unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Conivaptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Jun 2015
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Left ventricular ejection fraction (LVEF) < 45 % on the baseline echocardiography.
- Treatment with beta-blockers and angiotensin-converting-enzyme (ACE) inhibitors for at least 1 month as tolerated
- New York Heart Association (NYHA) Functional Class II-III
- Given informed consent
- Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will provide a negative urine HCG before entering the study
Who cannot join
- Signs of symptomatic or ongoing myocardial ischemia
- Known non-revascularized coronary disease
- Presence of hypovolemic hyponatremia (P-Na+ <130 mmol/l and clinical signs of volume depletion or dehydration as judged by investigator).
- Hypernatraemia (P-Na+) > 145 mmol/L
- Chronic obstructive pulmonary disease (FEV1/FVC < 70 % and/or 30 % > FEV1 < 50 %)
- Supine systolic blood pressure < 85 mmHg
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- Significant orthostatic hypotension
- Standing blood pressure < 80 mmHg or a blood pressure drop > 20 mmHg when changing from a supine to a standing position
- Uncontrolled hypertension evaluated by the investigator
- Uncontrolled cardiac arrhythmias evaluated by the investigator
- Untreated serious hypothyroidism
- Adrenal insufficiency
- Poor echocardiographic window
- Inability to perform exercise testing
- Permanent atrial fibrillation or atrial fluttering
- Planned coronary by-pass surgery
- Moderate hepatic impairment (ALAT/ASAT > 3 UNL)
- Presence of other diseases affecting treatment with conivaptan or the evaluation of safety as evaluated by the investigator
- Severely decreased kidney function (eGFR < 20 mL/min)
- Serum K+< 3.5 or > 5.5 mmol/L
- Known conivaptan intolerability
- Corn allergy
- Dextrose Allergy
- Treatment with potent CYP3A-inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir)
- Treatment with arginine vasopressin, oxytocin, desmopressin and other medications for the treatment of hyponatremia (lithium salts, urea and demeclocycline)
- Warfarin treatment
- Presence of infection or active bleeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Copenhagen University Hospital, Rigshospital
Copenhagen, 2100
About this study
The purpose of the present study is to evaluate the effects of a blockade of the vasopressin system and central hemodynamic system in heart failure (HF) patients during physical exercise. The significance of the vasopressin system during physical exercise is unclear. If vasopressin is a significant regulator of exercise hemodynamics in HF, strategies to intervene against activation of the V1A-receptor might be expected to improve HF symptoms and possibly outcome.
The potential effects of the central hemodynamic system will be evaluated with a Swan-Ganz catheter. Echocardiography will be performed at rest and during submaximal working capacity before and during the infusion of a vasopressin receptor antagonist (conivaptan) or placebo. Cardiac output will be measured by thermodilution. The exercise test will be performed at 50 % of VO2 max and hemodynamic and echocardiographic measurements will be collected. The exercise test will be performed on a supine multistage bicycle.
- Conditions
- Heart Failure
- Being tested
- Conivaptan, Placebo (Dextrose)
- Keywords
- Vasopressin, Exercise capacity, Conivaptan
- Medical subject headings
- Heart Failure, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConivaptanDrug
Also called Vaprisol
Conivaptan treatment: 20 mg bolus followed by infusion of 2 mg/hour
Placebo (Dextrose)Drug
Also called 5 % dextrose
Placebo treatment: 20 mg bolus followed by infusion of 2 mg/hour
| Study group | Role | What they receive |
|---|---|---|
| Conivaptan | Active comparator | 10 patients will be randomized to conivaptan treatment Receives: Drug: Conivaptan |
| Dextrose | Placebo comparator | 10 patients will receive placebo treatment (dextrose) Receives: Drug: Placebo (Dextrose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The joint endpoint of change in pulmonary capillary wedge pressure (PCWP) and cardiac output (CO) at the submaximal exercise intensity of 50 % of the maximal exercise capacity
Measured: 1 day
Secondary outcomes (5)
Cardiac index (CI) during submaximal exercise from rest to submaximal exercise
Measured: 1 day
Pulmonary and systemic vascular resistance from rest to submaximal exercise
Measured: 1 day
Left ventricular end diastolic diameter during exercise from rest to submaximal exercise
Measured: 1 day
The change in mean pulmonary artery pressure (mPAP) from rest to submaximal exercise
Measured: 1 day
The change in BNP, MR-ANP and copeptin from rest to submaximal exercise
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finn Gustafsson
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Louise Balling, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletFinn Gustafsson, MD, PhD, DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752543
- Sponsor's protocol ID
- H-3-2012-139
- Status last verified
- Jun 2015
- First submitted
- 12 Dec 2012
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balling L, Thomsen JH, Wolsk E, Hassager C, Boesgaard S, Goldsmith SR, Gustafsson F. Hemodynamic effects of short-term infusion of a vasopressin V1A/V2 receptor antagonist conivaptan in patients withchronic heart failure during submaximal exercise. Am Heart J. 2018 Sep;203:101-104. doi: 10.1016/j.ahj.2018.05.015. Epub 2018 Jun 14. No abstract available.
PubMed 30057012
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01752543
- Acronym / sponsor ID
- H-3-2012-139
- Conditions
- Heart Failure
- Keywords
- Vasopressin, Exercise capacity, Conivaptan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Finn GustafssonUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to evaluate the effects of a blockade of the vasopressin system and central hemodynamic system in heart failure (HF) patients during physical exercise. The significance of the vasopressin system during physical exercise is unclear. If vasopressin is a significant regulator of exercise hemodynamics in HF, strategies to intervene against activation of the V1A-receptor might be expected to improve HF symptoms and possibly outcome.
The potential effects of the central hemodynamic system will be evaluated with a Swan-Ganz catheter. Echocardiography will be performed at rest and during submaximal working capacity before and during the infusion of a vasopressin receptor antagonist (conivaptan) or placebo. Cardiac output will be measured by thermodilution. The exercise test will be performed at 50 % of VO2 max and hemodynamic and echocardiographic measurements will be collected. The exercise test will be performed on a supine multistage bicycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conivaptan | Active comparator | Drug: Conivaptan10 patients will be randomized to conivaptan treatment |
| Dextrose | Placebo comparator | Drug: Placebo (Dextrose)10 patients will receive placebo treatment (dextrose) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Left ventricular ejection fraction (LVEF) < 45 % on the baseline echocardiography.
- Treatment with beta-blockers and angiotensin-converting-enzyme (ACE) inhibitors for at least 1 month as tolerated
- New York Heart Association (NYHA) Functional Class II-III
- Given informed consent
Key exclusion criteria (27 listed)
- Signs of symptomatic or ongoing myocardial ischemia
- Known non-revascularized coronary disease
- Presence of hypovolemic hyponatremia (P-Na+ <130 mmol/l and clinical signs of volume depletion or dehydration as judged by investigator).
- Hypernatraemia (P-Na+) > 145 mmol/L
- Chronic obstructive pulmonary disease (FEV1/FVC < 70 % and/or 30 % > FEV1 < 50 %)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConivaptanAlso: VaprisolConivaptan treatment: 20 mg bolus followed by infusion of 2 mg/hour | Drug | Conivaptan |
| Placebo (Dextrose)Also: 5 % dextrosePlacebo treatment: 20 mg bolus followed by infusion of 2 mg/hour | Drug | Dextrose |
Primary outcome
The joint endpoint of change in pulmonary capillary wedge pressure (PCWP) and cardiac output (CO) at the submaximal exercise intensity of 50 % of the maximal exercise capacity
Time frame: 1 day
5 secondary outcomes
Cardiac index (CI) during submaximal exercise from rest to submaximal exercise
Time frame: 1 day
Pulmonary and systemic vascular resistance from rest to submaximal exercise
Time frame: 1 day
Left ventricular end diastolic diameter during exercise from rest to submaximal exercise
Time frame: 1 day
The change in mean pulmonary artery pressure (mPAP) from rest to submaximal exercise
Time frame: 1 day
The change in BNP, MR-ANP and copeptin from rest to submaximal exercise
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
- Derived from this study: PubMed 30057012Balling L, Thomsen JH, Wolsk E, Hassager C, Boesgaard S, Goldsmith SR, Gustafsson F. Hemodynamic effects of short-term infusion of a vasopressin V1A/V2 receptor antagonist conivaptan in patients withchronic heart failure during submaximal exercise. Am Heart J. 2018 Sep;203:101-104. doi: 10.1016/j.ahj.2018.05.015. Epub 2018 Jun 14. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Balling, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Finn Gustafsson, MD, PhD, DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conivaptan in people with Heart Failure, run by Finn Gustafsson at 1 site in Denmark.
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 6 inclusion and 27 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: finished, as of the sponsor's last update on 17 Jun 2015. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The joint endpoint of change in pulmonary capillary wedge pressure (PCWP) and cardiac output (CO) at the submaximal exercise intensity of 50 % of the maximal exercise capacity (time frame: 1 day). 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 NCT01752543, which also lists 1 linked publication.
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 17 Jun 2015.