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Heart FailurePhase 1NCT00565565

Single Dose Escalation Study in Patients With Chronic Heart Failure

A Phase 1 study testing BAY60-4552 in people with Heart Failure, run by Bayer at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
BAY60-4552
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesGermany
Study dates
Oct 2007to Apr 2009
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters

Who cannot join

  • Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Study site

    Bad Nauheim, Hesse, 61231

  • Study site

    Giessen, Hesse, 35392

Other trials in Germany

About this study

Official title: Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of a Single Oral Dose of BAY60-4552 in Patients With Biventricular Chronic Heart Failure and Pulmonary Hypertension in a Non-randomized, Non-blinded, Dose Escalation Design.

This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ECG, heart rate, blood pressure, adverse events). After a observation period the patient will be discharged from the hospital.

Conditions
Heart Failure
Being tested
BAY60-4552
Keywords
Biventriular chronic heart failure, Pulmonary hypertension
Medical subject headings
Heart Failure, Hypertension, Pulmonary

What participants receive

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

  • BAY60-4552Drug

    Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg

Study groups in NCT00565565
Study groupRoleWhat they receive
BAY60-4552, 1 mgExperimentalSubjects were planned to receive 1 mg of BAY60-4552 as solution
Receives: Drug: BAY60-4552
BAY60-4552, 2.5 mgExperimentalSubjects were planned to receive 2.5 mg of BAY60-4552 as tablet
Receives: Drug: BAY60-4552
BAY60-4552, 5 mgExperimentalSubjects were planned to receive 5.0 mg of BAY60-4552 as tablet
Receives: Drug: BAY60-4552
BAY60-4552, 7.5 mgExperimentalSubjects were planned to receive 7.5 mg of BAY60-4552 as tablet
Receives: Drug: BAY60-4552
BAY60-4552, 10 mgExperimentalSubjects were planned to receive 10 mg of BAY60-4552 as tablet
Receives: Drug: BAY60-4552

What is being measured

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

  1. Change in pulmonary capillary wedge pressure

    Measured: Pre-dose and up to 6 hr post-dose

  2. Change in mean pulmonary artery pressure

    Measured: Pre-dose and up to 6 hr post-dose

  3. AUC

    Area under the plasma concentration vs time curve from zero to infinity after single dose

    Measured: Pre-dose and up to 72 hr post-dose

  4. AUC/D

    AUC divided by dose (mg)

    Measured: Pre-dose and up to 72 hr post-dose

  5. Cmax

    Maximum drug concentration in plasma after single dose administration

    Measured: Pre-dose and up to 72 hr post-dose

  6. Cmax/D

    Cmax divided by dose (mg)

    Measured: Pre-dose and up to 72 hr post-dose

  7. Number of participants with adverse events

    Measured: Approximately 2 weeks

Secondary outcomes (35)

  1. Mean right atrial pressure

    Measured: Pre-dose and up to 6 hr post-dose

  2. Systolic pulmonary artery pressure

    Measured: Pre-dose and up to 6 hr post-dose

  3. Diastolic pulmonary artery pressure

    Measured: Pre-dose and up to 6 hr post-dose

  4. Heart rate

    Measured: At pre-study visit, pre-dose and up to 24 hr post-dose

  5. Cardiac output

    Measured: Pre-dose and up to 6 hr post-dose

  6. Pulmonary vascular resistance

    Measured: Pre-dose and up to 6 hr post-dose

  7. Pulmonary vascular resistance index

    Measured: Pre-dose and up to 6 hr post-dose

  8. Systemic vascular resistance

    Measured: Pre-dose and up to 6 hr post-dose

  9. Systemic vascular resistance index

    Measured: Pre-dose and up to 6 hr post-dose

  10. Cardiac index

    Measured: Pre-dose and up to 6 hr post-dose

  11. Mean arterial pressure

    Measured: Pre-dose and up to 6 hr post-dose

  12. Systemic blood pressure

    Measured: At pre-study visit, pre-dose and up to 24 hr post-dose

  13. Diastolic blood pressure

    Measured: At pre-study visit, pre-dose and up to 24 hr post-dose

  14. Dyspnea Score

    Subject is asked unpersuasively about his/her well-being in comparison to the baseline condition, measured on a 7-point Likert scale.

    Measured: Pre-dose and up to 48 hr post-dose

  15. AUC(0-6)

    AUC from time 0 to 6 h after study drug intake

    Measured: Pre-dose and up to 6 hr post-dose

  16. AUCnorm

    AUC divided by dose (mg) per kg body weight

    Measured: Pre-dose and up to 72 hr post-dose

  17. AUC(0-tn)

    AUC from time 0 to the last data point

    Measured: Pre-dose and up to 72 hr post-dose

  18. AUC(0-tn)norm

    AUC(0-tn) divided by dose (mg) per kg body weight

    Measured: Pre-dose and up to 72 hr post-dose

  19. Cmax,norm

    Cmax divided by dose (mg) per kg body weight

    Measured: Pre-dose and up to 72 hr post-dose

  20. tmax

    Time to reach maximum drug concentration in plasma after single dose

    Measured: Pre-dose and up to 72 hr post-dose

  21. t½

    Half-life associated with the terminal slope

    Measured: Pre-dose and up to 72 hr post-dose

  22. Mean residence time

    Measured: Pre-dose and up to 72 hr post-dose

  23. Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)

    Measured: Pre-dose and up to 72 hr post-dose

  24. Apparent volume of distribution associated with the terminal phase (after oral administration)

    Measured: Pre-dose and up to 72 hr post-dose

  25. Amount of drug excreted via urine

    Measured: Pre-dose and up to 6 hr post-dose

  26. Percent amount of drug excreted via urine

    Measured: Pre-dose and up to 6 hr post-dose

  27. Renal clearance of drug

    Measured: Pre-dose and up to 6 hr post-dose

  28. Renin activity

    Measured: Pre-dose and up to 24 hr post-dose

  29. Change from baseline of noradrenaline after drug administration

    Measured: Pre-dose and up to 24 hr post-dose

  30. N-terminal pro-atrial natriuretic peptide

    Measured: Pre-dose and up to 24 hr post-dose

  31. NT-pro B-type natriuretic peptide

    Measured: Pre-dose and up to 24 hr post-dose

  32. Big endothelin-1

    Measured: Pre-dose and up to 24 hr post-dose

  33. Cystatin C

    Measured: Pre-dose and up to 24 hr post-dose

  34. Change from baseline of osteopontin after drug administration

    Measured: Pre-dose and up to 24 hr post-dose

  35. Cyclic guanosine mono-phosphate

    Measured: Pre-dose and up to 24 hr post-dose

Timeline

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

  1. First posted30 Nov 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionDec 2008
  4. Study completionApr 2009

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00565565
Sponsor's protocol ID
12356
Other IDs
2007-003216-54
Status last verified
Aug 2016
First submitted
31 Oct 2007
Last updated
10 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Acute hemodynamic response to single oral doses of BAY 60-4552, a soluble guanylate cyclase stimulator, in patients with biventricular heart failure. V Mitrovic, B Swidnicki, A Ghofrani, W Mück, N Kirschbaum, J Mittendorf, J-P Stasch, G Wensing, R Frey, S Lentini. BMC Pharmacology 2009; 9(Suppl 1): P51.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY60-4552 in people with Heart Failure, run by Bayer at 2 sites in Germany.

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 1 inclusion and 1 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Change in pulmonary capillary wedge pressure (time frame: Pre-dose and up to 6 hr post-dose). The study lists 7 primary outcomes in all. 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 NCT00565565, 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 10 Aug 2016.

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